Brand Name | XIVE S PLUS IMPL D3.0/L13 |
Type of Device | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Manufacturer (Section D) |
DENTSPLY IMPLANTS MANUFACTURING GMBH |
rodenbacher chaussee 4 |
hanau hessen 63457 |
GM 63457 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS MANUFACTURING GMBH |
rodenbacher chaussee 4 |
|
hanau hessen 63457 |
GM
63457
|
|
Manufacturer Contact |
hannah
seevaratnam
|
221 west philadelphia st. |
york, PA 17401
|
7178457511
|
|
MDR Report Key | 14434328 |
MDR Text Key | 292020456 |
Report Number | 3013111692-2022-08035 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K032750 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
05/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Catalogue Number | 26-2413 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/16/2022 |
Initial Date Manufacturer Received |
05/16/2022
|
Initial Date FDA Received | 05/19/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|